Reported Nov 13, 2013 · Terminated
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery…
Insight Instruments, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insight Instruments, Inc. · 2580 Se Willoughby Blvd · Stuart, FL · 34994-4701
Is this the product you have?
- MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
- Lot codes and dates
- Part Number Lot Number Expiration
11007M5293404/201311017M5301704/201311007M5528507/201311007M5586908/201311007M5861012/201311007M5957502/201411007M6178105/2014
- Part Number Lot Number Expiration
- Amount recalled
- 10212
Where it was sold
Why it was recalled
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
This product could cause temporary or reversible health problems — stop using it.
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